Trial Outcomes & Findings for High Flow Nasal Cannula for Obstructive Sleep Apnea (NCT NCT03843372)

Last Updated: 2020-12-17

Results Overview

The Apnea Hypopnea Index(AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI under one night transnasal high flow therapy will be compared with one night continuous positive airway pressure.

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

2 days

Results posted on

2020-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	HFNC First, Then CPAP Participants first received high flow nasal cannula (HFNC) for one night. After a washout period of one week, they then received continuous positive airway pressure (CPAP) for one night.	CPAP First, Then HFNC Participants first received continuous positive airway pressure (CPAP) for one night. After a washout period of one week, they then received high flow nasal cannula (HFNC) for one night.
Overall Study STARTED	14	18
Overall Study COMPLETED	12	16
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High Flow Nasal Cannula for Obstructive Sleep Apnea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	First Night HFNC Group n=12 Participants The first night will receive high flow nasal cannula (HFNC) therapy and the second night accept continuous positive airway pressure (CPAP) therapy.	First Night CPAP Group n=16 Participants The first night will receive continuous positive airway pressure(CPAP) and the second accept high flow nasal cannula(HFNC) therapy.	Total n=28 Participants Total of all reporting groups
Age, Continuous	53.5 years n=99 Participants	53.5 years n=107 Participants	53.5 years n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	11 Participants n=107 Participants	21 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	12 Participants n=99 Participants	16 Participants n=107 Participants	28 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment Taiwan	12 participants n=99 Participants	16 participants n=107 Participants	28 participants n=206 Participants
BMI	30.1 kg/m^2 n=99 Participants	26.95 kg/m^2 n=107 Participants	27.4 kg/m^2 n=206 Participants
Neck circumference	41.5 cm n=99 Participants	37.5 cm n=107 Participants	38.5 cm n=206 Participants
AHI	51.65 events per hour n=99 Participants	26.9 events per hour n=107 Participants	34.9 events per hour n=206 Participants
DI	45.15 events per hour n=99 Participants	24.45 events per hour n=107 Participants	29.4 events per hour n=206 Participants
Sleep efficiency	80.7 % n=99 Participants	80.4 % n=107 Participants	80.4 % n=206 Participants
Total sleep time	324 minutes n=99 Participants	331.65 minutes n=107 Participants	330.15 minutes n=206 Participants

PRIMARY outcome

Timeframe: 2 days

Outcome measures

Outcome measures
Measure	CPAP n=28 Participants The polysomnography data of 28 participants treated with one night CPAP.	HFNC n=28 Participants The polysomnography data of 28 participants received one night HFNC therapy.
Apnea Hypopnea Index	6.15 events per hour Interval 2.63 to 8.28	14.85 events per hour Interval 6.85 to 27.3

PRIMARY outcome

Timeframe: 2 days

The oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by 3% degree from baseline.The ODI under one night transnasal high flow therapy will be compared with one night continuous positive airway pressure.

Outcome measures

Outcome measures
Measure	CPAP n=28 Participants The polysomnography data of 28 participants treated with one night CPAP.	HFNC n=28 Participants The polysomnography data of 28 participants received one night HFNC therapy.
Oxygen Desaturation Index	1.25 events per hour Interval 0.4 to 4.0	5.25 events per hour Interval 2.08 to 21.55

SECONDARY outcome

Timeframe: 2 days

The total amount of sleep time spent during a study period.

Outcome measures

Outcome measures
Measure	CPAP n=28 Participants The polysomnography data of 28 participants treated with one night CPAP.	HFNC n=28 Participants The polysomnography data of 28 participants received one night HFNC therapy.
Total Sleep Time	343 minutes Interval 333.25 to 366.5	292.75 minutes Interval 265.63 to 325.0

SECONDARY outcome

Timeframe: 2days

Sleep efficiency is the percentage of the total time spent asleep compared to the total amount of recording time.

Outcome measures

Outcome measures
Measure	CPAP n=28 Participants The polysomnography data of 28 participants treated with one night CPAP.	HFNC n=28 Participants The polysomnography data of 28 participants received one night HFNC therapy.
Sleep Efficiency	86.1 percentage of sleep time Interval 80.15 to 90.43	74.25 percentage of sleep time Interval 65.8 to 80.75

Adverse Events

CPAP

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

HFNC

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CPAP n=28 participants at risk The polysomnography data of 28 participants received one night CPAP therapy.	HFNC n=28 participants at risk The polysomnography data of 28 participants received one night HFNC therapy.
Product Issues Too strong airflow	0.00% 0/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP. CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.	17.9% 5/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP. CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
Product Issues CPAP Mask or HFNC cannula discomfort	21.4% 6/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP. CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.	3.6% 1/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP. CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
General disorders Frequent awakenings	7.1% 2/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP. CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.	17.9% 5/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP. CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
Product Issues Too hot airflow	0.00% 0/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP. CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.	17.9% 5/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP. CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
General disorders Nasal stuffiness	0.00% 0/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP. CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.	21.4% 6/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP. CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
General disorders dry nose or throat	7.1% 2/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP. CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.	7.1% 2/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP. CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.

Additional Information

Dr. Chung-Chieh Yu

Sleep Center, Chang Gung Memorial Hospital, Keelung, Taiwan

Phone: 886+22432-9292

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place